DementiaNCT06725251
The Impact of Art Therapy on the Relationships Between Individuals Diagnosed With Alzheimer's Disease and Their Care Partners
A study testing Art Therapy in people with Dementia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of a 4-week art therapy intervention on the relationships between individuals diagnosed with Alzheimer's disease and their care partners, on the self-esteem of diagnosed individuals, and on care partner attitudes towards persons with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2016to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Alzheimer's disease, based on the NIA/AA Diagnostic Guidelines for Alzheimer's Disease (McKhann et al., 2011)
- MMSE of 18-26, inclusive, administered within 6 month prior to screening or at screening
- Awareness of diagnosis and/or memory impairment, as determined by semi-structured interview with clinician (see Appendix B)
- Availability and willingness to participate in all 4 sessions of the intervention
- A care partner with whom the patient has regular weekly contact and who is available and willing to participate in all 4 sessions of the intervention
- Sufficient visual acuity to read 12-point font
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- Sufficient manual dexterity to use scissors
- Ability to hear instructions in a classroom setting
- Ability to read English
- Age 18 years old or greater
- Adult 18 years of age or older
- Ability to consent
- Regular weekly contact with the subject diagnosed with Alzheimer's disease
- Availability and willingness to participate in all 4 sessions of the intervention
- Sufficient visual acuity to read 12-point font
- Sufficient manual dexterity to use scissors
- Ability to hear instructions in a classroom setting
- Ability to read English
Who cannot join
- Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, fronto-temporal dementia, head trauma).
- Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
- Current active seizure disorder.
- Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
- Recent history (within 1 year) of alcohol abuse or drug abuse.
- Active tobacco use that interferes with visits (e.g., if the patient would need to smoke during the therapy session).
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- Use of medications (e.g., narcotics, sedatives, etc.) that lead to drowsiness during the therapy sessions
- Inability to comply with the instructions of the art therapist.
- Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
- Prisoners
- Any uncontrolled medical or neurological/neurodegenerative condition sufficient to cause cognitive impairment
- Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
- Current active seizure disorder.
- Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
- Recent history (within 1 year) of alcohol abuse or drug abuse.
- Active tobacco use that interferes with visits (e.g., if the care partner would need to smoke during the therapy session).
- Use of medications (e.g., narcotics, sedatives, etc.) that lead to drowsiness during the therapy sessions
- Inability to comply with the instructions of the art therapist.
- Other unspecified reasons that, in the opinion of the Investigator make the care partner unsuitable for enrollment.
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact of a 4-week art therapy intervention on the relationships between individuals diagnosed with Alzheimer's disease and their care partners, on the self-esteem of diagnosed individuals, and on care partner attitudes towards persons with Alzheimer's disease.
Read the detailed description
The aim is to develop and implement an art therapy intervention for dyads - each consisting of an individual diagnosed with mild Alzheimer's disease and his/her care partner - with the goals of improving patients' and care partners' sense of their relationship, increasing patients' self-esteem and improving care partner attitudes towards individuals with Alzheimer's disease. The specific intervention will be a portrait-making project utilizing a collage approach. Each participant (i.e. diagnosed individuals and care partners) will be instructed to create a portrait of him/herself. Participants will be provided with a sample portrait as well as bins of materials (e.g. words, images, markers). The intervention will be administered for 1 ½ hours weekly, at the same day/time, for 4 consecutive weeks.
- Conditions
- Dementia
- Being tested
- Art Therapy
- Keywords
- self esteem, caregiver, art therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
Dyads will take part in a portrait-making project utilizing a collage approach. Each participant (i.e. dementia diagnosed individuals and care partners) will be instructed to create a portrait of him/herself. Participants will be provided with a sample portrait as well as bins of materials. ]The intervention will be administered for 1 ½ hours weekly, at the same day/time, for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Participants and Care Partners | Experimental | Dyads including a participant diagnosed with dementia and the care partner Receives: Behavioral: Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Art Therapy on Quality of Dyadic Relationship
Impact of art therapy on quality of dyadic relationship will be determined using the Dyadic Relationship Scale. The survey consists of 10 questions with a total score range of 10-40. The score is a measure of patient and care partner perceptions of their relationship. Lower scores indicate the perception of a poorer relationship (i.e. greater strain, lower positive interactions) and higher scores indicate a perceived better relationship (i.e. lower strain, greater positive interactions).
Measured: Week 1
Impact of Art Therapy on Quality of Dyadic Relationship
Impact of art therapy on quality of dyadic relationship will be determined using the Dyadic Relationship Scale. The survey consists of 10 questions with a total score range of 10-40. The score is a measure of patient and care partner perceptions of their relationship. Lower scores indicate the perception of a poorer relationship (i.e. greater strain, lower positive interactions) and higher scores indicate a perceived better relationship (i.e. lower strain, greater positive interactions).
Measured: Week 4
Secondary outcomes (6)
Impact of Art Therapy on Dementia Individuals' Self-esteem
The impact of art therapy on the dementia diagnosed individuals' self-esteem will be determined by the Rosenberg Self-Esteem Scale. The survey consists of 10 questions with a total score range of 0-30. The score is a measure of patient self-esteem, with lower scores meaning lower self-esteem and higher scores meaning higher self-esteem.
Measured: Week 1
Impact of Art Therapy on Dementia Individuals' Self-esteem
The impact of art therapy on the dementia diagnosed individuals' self-esteem will be determined by the Rosenberg Self-Esteem Scale. The survey consists of 10 questions with a total score range of 0-30. The score is a measure of patient self-esteem, with lower scores meaning lower self-esteem and higher scores meaning higher self-esteem.
Measured: Week 4
Impact of Art Therapy on Dementia Individuals' Sense of Stigma
The impact of art therapy on diagnosed individuals' sense of stigma will be determined by the Stigma Impact Scale. The survey consists of 20 questions with a total score range of 0-80. The score is a measure of the patient's perception of stigma, with lower scores indicating lower perceived stigma and higher scores indicating greater perceived stigma.
Measured: Week 1
Impact of Art Therapy on Dementia Individuals' Sense of Stigma
The impact of art therapy on diagnosed individuals' sense of stigma will be determined by the Stigma Impact Scale. The survey consists of 20 questions with a total score range of 0-80. The score is a measure of the patient's perception of stigma, with lower scores indicating lower perceived stigma and higher scores indicating greater perceived stigma.
Measured: Week 4
Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia
The impact of art therapy on care partner attitudes towards persons with dementia will be determined by the Dementia Attitudes Scale. The survey consists of 20 questions with a total score range of 20-140. The score is a measure of care partner attitudes towards patients with dementia. Lower scores indicate lower knowledge and social comfort with persons with dementia and a higher score indicates greater knowledge and social comfort with persons with dementia.
Measured: Week 1
Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia
The impact of art therapy on care partner attitudes towards persons with dementia will be determined by the Dementia Attitudes Scale. The survey consists of 20 questions with a total score range of 20-140. The score is a measure of care partner attitudes towards patients with dementia. Lower scores indicate lower knowledge and social comfort with persons with dementia and a higher score indicates greater knowledge and social comfort with persons with dementia.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start26 Aug 2016
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- James R. and Helen D. Russell Center for Research and Innovation
- Responsible party
- Sponsor
- Investigators
- Darren Gitelman, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725251
- Sponsor's protocol ID
- IRB00106942
- Other IDs
- 6409, 2016-102
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Art Therapy on the Relationships Between Individuals Diagnosed With Alzheimer's Disease and Their Care Partners
- ClinicalTrials.gov ID
- NCT06725251
- Acronym / sponsor ID
- IRB00106942
- Conditions
- Dementia
- Keywords
- self esteem, caregiver, art therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- James R. and Helen D. Russell Center for Research and Innovation
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of a 4-week art therapy intervention on the relationships between individuals diagnosed with Alzheimer's disease and their care partners, on the self-esteem of diagnosed individuals, and on care partner attitudes towards persons with Alzheimer's disease.
Detailed description
The aim is to develop and implement an art therapy intervention for dyads - each consisting of an individual diagnosed with mild Alzheimer's disease and his/her care partner - with the goals of improving patients' and care partners' sense of their relationship, increasing patients' self-esteem and improving care partner attitudes towards individuals with Alzheimer's disease. The specific intervention will be a portrait-making project utilizing a collage approach. Each participant (i.e. diagnosed individuals and care partners) will be instructed to create a portrait of him/herself. Participants will be provided with a sample portrait as well as bins of materials (e.g. words, images, markers). The intervention will be administered for 1 ½ hours weekly, at the same day/time, for 4 consecutive weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia Participants and Care Partners | Experimental | Behavioral: Art TherapyDyads including a participant diagnosed with dementia and the care partner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- A diagnosis of Alzheimer's disease, based on the NIA/AA Diagnostic Guidelines for Alzheimer's Disease (McKhann et al., 2011)
- MMSE of 18-26, inclusive, administered within 6 month prior to screening or at screening
- Awareness of diagnosis and/or memory impairment, as determined by semi-structured interview with clinician (see Appendix B)
- Availability and willingness to participate in all 4 sessions of the intervention
- A care partner with whom the patient has regular weekly contact and who is available and willing to participate in all 4 sessions of the intervention
Key exclusion criteria (20 listed)
- Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, fronto-temporal dementia, head trauma).
- Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
- Current active seizure disorder.
- Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
- Recent history (within 1 year) of alcohol abuse or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art TherapyDyads will take part in a portrait-making project utilizing a collage approach. Each participant (i.e. dementia diagnosed individuals and care partners) will be instructed to create a portrait of him/herself. Participants will be provided with a sample portrait as well as bins of materials. ]The intervention will be administered for 1 ½ hours weekly, at the same day/time, for 4 consecutive weeks. | Behavioural | Dementia Participants and Care Partners |
Primary outcome
Impact of Art Therapy on Quality of Dyadic Relationship
Time frame: Week 1
Impact of art therapy on quality of dyadic relationship will be determined using the Dyadic Relationship Scale. The survey consists of 10 questions with a total score range of 10-40. The score is a measure of patient and care partner perceptions of their relationship. Lower scores indicate the perception of a poorer relationship (i.e. greater strain, lower positive interactions) and higher scores indicate a perceived better relationship (i.e. lower strain, greater positive interactions).
Impact of Art Therapy on Quality of Dyadic Relationship
Time frame: Week 4
Impact of art therapy on quality of dyadic relationship will be determined using the Dyadic Relationship Scale. The survey consists of 10 questions with a total score range of 10-40. The score is a measure of patient and care partner perceptions of their relationship. Lower scores indicate the perception of a poorer relationship (i.e. greater strain, lower positive interactions) and higher scores indicate a perceived better relationship (i.e. lower strain, greater positive interactions).
6 secondary outcomes
Impact of Art Therapy on Dementia Individuals' Self-esteem
Time frame: Week 1
Impact of Art Therapy on Dementia Individuals' Self-esteem
Time frame: Week 4
Impact of Art Therapy on Dementia Individuals' Sense of Stigma
Time frame: Week 1
Impact of Art Therapy on Dementia Individuals' Sense of Stigma
Time frame: Week 4
Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia
Time frame: Week 1
Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Gitelman, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy in people with Dementia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Art Therapy on Quality of Dyadic Relationship (time frame: Week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.